Our DNA can’t be patented

In the late 1990s, the United States Patent Office issued patents to a Utah company on two human genes called BRCA1 and BRCA2, genes that — if present — cause a significantly elevated risk of breast and ovarian cancer.

The patents gave the company — Myriad Genetics — a monopoly on testing women for the presence of those genes. Armed with its patents, the company went after academic and medical researchers to stop them from trying to test for the genes and jacked the price of its test up to as much as $4,000.

Yesterday, the U.S. Supreme Court ruled that the Patent Office was wrong. In its unanimous ruling in the case of Association for Molecular Pathology v. Myriad Genetics, the Court held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.”1

In other words, nobody can get a patent on genes that occur naturally in your body or mine. And that is Very Good News, indeed.

The Court explained that what Myriad did was discover “the precise location and sequence of what are now known as the BRCA1 and BRCA2 genes.” It went on:

Mutations in these genes can dramatically increase an individual’s risk of developing breast and ovarian cancer. The average American woman has a 12- to 13-percent risk of developing breast cancer, but for women with certain genetic mutations, the risk can range between 50 and 80 percent for breast cancer and between 20 and 50 percent for ovarian cancer.2

It reviewed the bottom line in American jurisprudence on the patentability of purely natural phenomena:

We have “long held that …[:] Laws of nature, natural phenomena, and abstract ideas are not patentable.” … Rather, “‘they are the basic tools of scientific and technological work’” that lie beyond the domain of patent protection. … As the Court has explained, without this exception, there would be considerable danger that the grant of patents would “tie up” the use of such tools and thereby “inhibit future innovation premised upon them.” … This would be at odds with the very point of patents, which exist to promote creation.3

In striking down the Myriad Genetics’ patents on the BRCA1 and BRCA2 genes, the Court noted that:

It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA. Instead, Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13. … Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.4

The Court was careful to limit its holding to the patent on the genes themselves, and not to the creation of artificial versions of the genetic material in the laboratory. And there’s nothing in the opinion that will stop the Patent Office from issuing a patent on a treatment for a genetic ailment or a particular method of manipulating DNA in order to detect a genetic ailment.

Those activities are useful scientific advances that work to everyone’s advantage and help achieve the purposes of the patent statutes: to promote creation.

However, between this decision yesterday and the decision by the Supreme Court last year in Mayo Medical Labs. v. Prometheus Labs.,5 it’s clear that the Court will not allow companies to use the patent laws to lock up genes or parts of genes occurring in nature nor to claim a monopoly on the mere fact that having gene A results in a higher-than-average risk of condition B.

• Third, nobody else can tell us that we can’t test a specific part of our DNA that may contain information useful for family history (including family medical history).

• Fourth, nobody else can tell us that the only way we can test a specific part of our DNA that may contain information useful for family history (including family medical history) is to pay one company a price it can inflate to its heart’s content because there’s no competition.

If you think I’m overstating the case here, read yesterday’s blog post “Supreme Court Decision – Genes Can’t Be Patented” by Roberta Estes at DNA-Explained. She quotes Gene by Gene, parent company of Family Tree DNA, as stating it could do the BRCA1 and BRCA2 testing — and will immediately start doing so through its DNATraits division — for less than one fourth the amount Myriad Genetics has been charging.6

Now I want to repeat what I wrote about this issue last year, because I do have a dog in this hunt and my views on this issue are distinctly biased. I wrote then:

I am a breast cancer survivor. I was faced a few years ago with the question of whether to have a genetic test for the BRCA1 and BRCA2 genes that greatly enhance a woman’s chances of developing breast and/or ovarian cancer. Because of a lack of family history and the specific kind of cancer I had, my insurance company was unwilling to pay for the test.

One hitch: Myriad Genetics holds the patent on the BRCA1 and BRCA2 genes. … Myriad Genetics didn’t create the gene, or change the person’s status or condition, or change the fact that people with BRCA1 or BRCAC2 have an elevated risk of cancer. All it did was patent the connection and say nobody else could test for BRCA1 and BRCA2.

And because of Myriad’s patent — a patent that’s been challenged in the courts for years without final resolution — I couldn’t shop around. I had one choice for the test — Myriad — and the cost would have been more than $4,000.

After consulting with a genetic counselor, I opted not to have the test. But at least, for me, it was an option. If my life had been on the line, I could have found the $4,000. For many women, coming up with that much cash is out of the question, especially in light of all the other costs of cancer treatment.7

It is, therefore, with profound personal as well as genealogical relief that I can say, today, it looks like the Supreme Court is Getting This Right.

Share this:

13 Comments

Mary Ann Thurmond on June 14, 2013 at 1:07 pm

I’m sure this decision brings relief to a lot of people, Judy. I’m not aware of any risk to me from the particular genes, but I’m relieved about the decision, (1) because I was mortified that one company could put many people in danger due to their inability to get tested, and (2) because I know and love some of those people, which made it more personal to me.

I’ve disagreed with too many of the more recent SCOTUS decisions, but applaud this one! Discovering a gene is no different than discovering an element or a new star. They might be able to patent the test they developed, but certainly not the gene itself. Bravo!

Thanks for writing about this. This is the first I had heard about this case. I am glad they are finally getting this right. I know several women who were faced with having to pay the $4000 to get tested or find a minimum of 3 female family members who have been diagnosed or perished from the disease before insurance will cover it. Even if they do cover it, it still costs around $300 for NC State employees.

I am also familiar with how the patents work, being a Drug Discovery scientist and having filed for a patent myself. We do not always patent the drugs themselves, but we do file for how we make them or “discover” them.

BRCA1 and 2 couldn’t be included in the 23andMe testing because of the Myriad patent, Ginger, and probably won’t be added now because of the impact on the cost. But DNATraits, a division of Gene by Gene (parent of Family Tree DNA) is already launching a competing test — for $995. One fourth of what Myriad charged.

I appreciate your insight. However, I’m a little confused about what 23andMe has already been testing and reporting to customers.

“No copies of the three early-onset breast and ovarian cancer mutations identifiable by 23andMe” [the 185delAG BRCA1 mutation, the 5382insC BRCA1 mutation and the 6174delT BRCA2 mutation]. “May still have a different mutation in BRCA1 or BRCA2.”

Are these different locations than those covered by Myriad’s now disallowed patent?

Judy G. Russell on June 15, 2013 at 9:11 am

Yes, they are, Dave. 23andMe states: “The BRCA Cancer Mutations (Selected) report includes 3 selected BRCA mutations. The BRCA mutations covered by this report are only three of hundreds in the BRCA1 and BRCA2 genes that can cause cancer. Their absence does not rule out the possibility that you may carry another cancer-causing variation in one of those genes.” Myriad’s patent covered those other areas.

Thanks for the clarification Judy. I thought I had seen a BRCA gene listed in the 23andme panel which is why I asked. But I see now that they only tested a couple of mutations associated with the gene. And they are not the “big” ones covered in all the literature. I didn’t test with 23andme but I did compare my values reported by my Family Finder test with the values reported by 23andme. I tried to look up the values reported on the BRCA genes they used but had trouble finding them because they are not the “big ones.” That’s great that Gene by Gene is launching a competing test.

Judy G. Russell on June 15, 2013 at 7:57 pm

You understand it exactly right, Ginger — they are not the “big” ones in the 23andMe test.

Lisa Marker on June 17, 2013 at 5:57 pm

I did not understand all of the details until reading this article. I am amazed that Myriad Genetics was originally able to patent the genes, and exceedingly relieved that someone challenged them. A wrong has been righted.

Archives

We use cookies on this website to ensure that the site will work properly on your web browser together with improving the site’s performance. If you click "Yes, I agree," you are agreeing to our use of cookies.Yes, I agreePrivacy Policy